FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN- octinoxate, oxybenzone liquid 
Merle Norman

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Merle Norman Flawless Effect Liquid Foundation SPF 15

Active Ingredients

Octinoxate 7.50%

Oxybenzone 3.00%

Uses
· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away

Stop use and ask a doctor if rash occurs

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Directions
For Sunscreen Use:
· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating
· Reapply at least every 2 hours

· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses
· Children under 6 months: Ask a doctor

Water(aqua), cyclopentasiloxane , mica, titanium dioxide, diisostearyl malate, ethylhexyl palmitate, glycerin, pentylene glycol, peg-30 dipolyhydroxystearate, iron oxides, propylene glycol, cyclohexasiloxane, aluminum starch octenylsuccinate, disteardimonium hectorite, hdi/ppg/polycaprolactone crosspolymer, glyceryl oleate, glyceryl stearate, myristyl myristate, polyglyceryl-3 beeswax, lecithin, disodium stearoyl glutamate, Butylene Glycol,  sodium hyaluronate, camellia oleifera leaf extract, ginkgo biloba leaf extract, chamomilla recutita (matricaria) flower extract, tetrahexyldecyl ascorbate, tocopheryl acetate, aluminum hydroxide (Cl 77002), silica, alcohol denat., BHT, phenoxyethanol, methylparaben, propylparaben

Flawless Effect Liquid Foundation SPF 15

Merle Norman

30 mL 1 FL. OZ.

Bottle

Box

FLAWLESS EFFECT LIQUID FOUNDATION SPF 15  MERLE NORMAN
octinoxate, oxybenzone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57627-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.9 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
FERROUS OXIDE (UNII: G7036X8B5H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
GLYCERYL 1-OLEATE (UNII: D3AEF6S35P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
GINKGO (UNII: 19FUJ2C58T)  
CHAMOMILE (UNII: FGL3685T2X)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57627-113-021 in 1 CARTON04/25/2011
1NDC:57627-113-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/25/2011
Labeler - Merle Norman (008479388)
Registrant - Merle Norman (008479388)
Establishment
NameAddressID/FEIBusiness Operations
Merle Norman008479388manufacture(57627-113)

Revised: 1/2020
Document Id: 5a5ff94d-4c04-46cb-bb76-64943513c02f
Set id: 05615352-186b-4610-a719-16fc36e09bb3
Version: 17
Effective Time: 20200127
 
Merle Norman